Administering Convalescent Plasma Rich With Neutralizing Abs. to Hospitalized Adults With WNV - a Double-blind Randomized Controlled Study
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Name of the study: Administering neutralizing convalescent plasma to hospitalized patients with West Nile fever - a double-blind randomized controlled study. The purpose of this study is to test the safety and effectiveness of giving blood plasma from convalescents rich in neutralizers as treatment against West Nile fever.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Hospitalized patients with positive WNV-PCR with fever/neurological symptoms, and 72 hours have not yet passed since the positive result.
• Age 60 or older.
• Age over 18 and younger than 60 with immunosuppression (hypogammaglobulinemia, solid organ transplants, bone marrow transplants, hemato-oncological malignancies).
Locations
Other Locations
Israel
Sheba Medical Center
Ramat Gan
Time Frame
Start Date: 2024-07-04
Completion Date: 2025-03-30
Participants
Target number of participants: 200
Treatments
Experimental: 200ml of neutralizing plasma
The plasma of the convalescents: produced in the blood bank of Sheba Medical Center, from the blood of Sheba workers who participated in the SPRI study (Helsinki 0196-23) and whose blood was found to have neutralizing antibodies to WNV (above 1:524). The blood units from the volunteers who will donate will meet all the requirements of a normal blood donation and will only include men or women who were not pregnant, and the units will pass all the tests accepted at the blood bank before donation.
Placebo_comparator: Saline
200 ml Saline
Related Therapeutic Areas
Sponsors
Leads: Sheba Medical Center